CAN/CSA-ISO 10993.1-98:1998 Edition

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Biological Evaluation of Medical Devices – Part 1: Guidance on Selection of Tests

Published By	Publication Date	Number of Pages
CSA	1998	25

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Category: CSA

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Description

Scope

This part of ISO 10993 gives guidance on

(a) the fundamental principles governing the biological evaluation of medical devices;
(b) the definition of categories of devices based on the nature and duration of contact with the body;
(c) the selection of appropriate tests.

ISO 10993 does not cover testing of materials and devices that do not come into contact with the patients body directly or indirectly. Nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword. (See A.2, clause 1 Scope.)

Additional information